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GILTUSS PEDIATRIC (Gil Pharmaceutical Corp)

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SOLUTION/ DROPS 1 BOTTLE in 1 CARTON (58552-121-02) > 60 mL in 1 BOTTLE Label Information

Complete GILTUSS PEDIATRIC Information

  • Active ingredients

    (in each 1 mL)

    Dextromethorphan HBr, 7.5 mg

    Guaifenesin, 88 mg

    Phenylephrine HCI, 2.5 mg

  • Purposes

    Antitussive

    Expectorant

    Nasal Decongestant

  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
    • temporarily relieves nasal congestion due to a cold
  • Warnings

    Do not use
    • in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

    Ask a doctor before use if you have
    • a child who has heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a doctor
    • a cough with too much phlegm (mucus)
    • a persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor

    When using this product
    • Do not exceed recommended dosage

    Stop use and ask a doctor if
    • nervousness, dizziness, or sleeplessness occur
    • cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    • do not exceed recommended dosage
    • take every 6 - 8 hours
    • administer using the spill guard dispenser and syringe that's provided
    children 6 to under 12 years of age 2 mL
    children 2 to 6 years of age 1 mL
    children under 2 years of age Consult a doctor
  • Other information

    • Tamper evident: Do not use if safety seal is broken or missing
    • Store at controlled room temperature, between 15°- 30° C (59° - 86° F)

    INSTRUCTIONS FOR USING THE ORAL LIQUID SPILL GUARD DISPENSER AND SYRINGE (INSTRUCCIONES PARA USAR EL "SPILL GUARD DISPENSER" Y LA JERINGUILLA PARA EL LIQUIDO ORAL)

    1. Remove the child resistant cap and insert the Spill Guard Dispenser (B) into the bottle (A). Insert syringe (C) into Spill Guard Dispenser opening.

    1. (Remueva la tapa resistente a niños. Introduzca en la botella (A) el "Spill Guard Dispenser" (B) Introduzca la jeringuilla (C) por la abertura del "Spill Guard Dispenser".)

    Image for Step 1

    2. Turn bottle with Spill Guard Dispenser and syringe upside down and withdraw the required amount.

    2. (Invierta la botella con el "Spill Guard Dispenser" y la jeringuilla y extragia la cantidad requerida.)

    Image for Step 2

    3. Return bottle to upright position. Remove the syringe and administer the medicine. Clean the syringe for next use. Leave Spill Guard Dispenser in bottle and replace child resistant cap.

    3. (Vuelva a invertir toda la unidad a su posición original. Remueva la jeringuilla y administre la medicina. Lave la jeringuilla para su próximo uso. Deje puesto el "Spill Guard Dispenser" en la botella y ciérrela nuevamente con la tapa resistente a niños.)

    Image for Step 3

  • Inactive ingredients

    Artificial grape and vanilla flavor, bitter mask, citric acid, grapeskin extract, menthol, monoammonium glycyrrhizinate, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose. Sodium citrate may be used to adjust pH.

  • Questions or comment?

    Call 1-877-746-9114, Mon. -Fri. 8:00 am thru 5:00 pm EST. Call your doctor for medical advice in the event of side effects.


    Rev. 323:01 6/10

  • Package/Label Principal Display Panel

    Image of Carton - 60 mL

    NDC 58552-121-02

    GILTUSS PEDIATRIC®

    NEW IMPROVED FORMULA

    ANTITUSSIVE, EXPECTORANT, NASAL DECONGESTANT

    Sugar Free & Alcohol Free

    No Artificial Dyes

    Easier Dosing for Children

    Unique Dispenser for Exact Dosing

    With Spill Guard Dispenser

    Child Resistant Cap

    Each 1 mL contains:

    Dextromethorphan HBr..................................7.5 mg

    Guaifenesin......................................................88 mg

    Phenylephrine HCl..........................................2.5 mg

    2 Fl. Oz. (60 mL)

    MANUFACTURED FOR:

    GIL PHARMACEUTICAL CORP.

    PONCE, PUERTO RICO 00717-1565

  • INGREDIENTS AND APPEARANCE
    GILTUSS PEDIATRIC 
    dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:58552-121
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 7.5 mg  in 1 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 88 mg  in 1 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
    MENTHOL (UNII: L7T10EIP3A)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCYRRHIZIN, AMMONIATED (UNII: 3VRD35U26C)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Color PURPLE (clear, purple) Score     
    Shape Size
    Flavor GRAPE (artificial grape flavor and grapeskin extract powder) , VANILLA (artificial vanilla flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58552-121-02 1 in 1 CARTON
    1 60 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 10/19/2009
    Labeler - Gil Pharmaceutical Corp (176826592)
    Registrant - Hi-Tech Pharmacal Co., Inc. (101196749)
    Establishment
    Name Address ID/FEI Business Operations
    Hi-Tech Pharmacal Co., Inc. 101196749 MANUFACTURE
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